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Education Program to Promote Female Condom Use

Primary Purpose

HIV Infections

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Female condom skills training
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for HIV Infections focused on measuring Female condom use, Male condom use, AIDS education, AIDS prevention, HIV Seronegativity

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria African American, Asian American, Latina, or White Two or more male sexual partners in the year prior to study entry English speaking Exclusion Criteria Commercial sex workers Planning to move within 6 months of study entry Allergic to polyurethane, latex, or lubricants

Sites / Locations

  • Center for AIDS Prevention Studies, University of California, San FranciscoRecruiting

Outcomes

Primary Outcome Measures

percent of sex acts protected by female condoms

Secondary Outcome Measures

percent of sex acts protected by male or female condoms

Full Information

First Posted
June 9, 2003
Last Updated
June 23, 2005
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00062634
Brief Title
Education Program to Promote Female Condom Use
Official Title
Female Condom Intervention Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2004
Overall Recruitment Status
Unknown status
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

5. Study Description

Brief Summary
The female condom offers women a potentially important option for HIV prevention. This study will develop and evaluate a health education program to increase female condom use among ethnically diverse women.
Detailed Description
AIDS incidence among women has grown at alarming rates since 1985. Heterosexual contact is now the greatest risk for HIV infection in women. Women in the United States urgently need more options to protect themselves against HIV. Nonetheless, limited prevention efforts have targeted women. The female condom is a potentially important option for HIV prevention in women. However, little research has been conducted to identify effective approaches to promote the female condom as the only female-controlled barrier method available to date. This study will develop a theoretically and empirically based intervention to increase female condom use among ethnically diverse women who engage in multiple sexual partnerships. The proposed female condom skills training intervention applies social cognitive theory. It also incorporates our extensive previous research that examined female condom acceptability and identified the attitudinal, interpersonal, and sociocultural factors affecting female condom use. The intervention consists of four sessions: 1) individual safer sex education and condom use skills training; 2) group discussion of barriers to female condom use; 3) group condom negotiation skills training; and 4) individual condom use counseling. The efficacy of the intervention will be assessed by comparing it to a control condition intervention that focuses on women's general health issues unrelated to HIV/AIDS. The control condition intervention has four sessions: 1) individual health education; 2) group discussion of women's health problems and related risk behaviors; 3) group discussion of healthy living; and 4) individual health risk reduction counseling. This study will use a randomized clinical trial design. Study participants will be randomly assigned to one of two conditions: female condom skills training or women's general health promotion. All participants will be interviewed at study entry, 3 months, and 6 months. Attitudinal, psychosexual, and behavioral data will be collected to evaluate the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Female condom use, Male condom use, AIDS education, AIDS prevention, HIV Seronegativity

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Female condom skills training
Primary Outcome Measure Information:
Title
percent of sex acts protected by female condoms
Secondary Outcome Measure Information:
Title
percent of sex acts protected by male or female condoms

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria African American, Asian American, Latina, or White Two or more male sexual partners in the year prior to study entry English speaking Exclusion Criteria Commercial sex workers Planning to move within 6 months of study entry Allergic to polyurethane, latex, or lubricants
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wendy Hussey, MPH
Phone
415-597-9340
Email
whussey@psg.ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung-Hee Choi, PhD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for AIDS Prevention Studies, University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wendy Hussey, MPH
Phone
415-597-9340
Email
whussey@psg.ucsf.edu
First Name & Middle Initial & Last Name & Degree
Kyung-Hee Choi, PhD, MPH
Phone
415-597-9281
Email
khchoi@psg.ucsf.edu
First Name & Middle Initial & Last Name & Degree
Kyung-Hee Choi, PhD, MPH

12. IPD Sharing Statement

Learn more about this trial

Education Program to Promote Female Condom Use

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